The publication of ISO/DIS 9001:2014 signifies the first time all current and future users can access and review the proposed changes to ISO 9001, signalling the unofficial beginning of the transition process for organisations.

The introduction of Annex SL, which establishes a consistent structure featuring 10 clauses as well as common terminology and definitions applicable to all ISO Management System Standards (MSS), is the biggest change to the ISO/DIS 9001:2014 document. Other topics that are new to ISO 9001 include: a] organisational context (clause 4), b] knowledge (clause 7), c] the control of externally provided products and services (outsourcing, clause 8) and the formal introduction of d] risk-based approach (several clauses), among others.

What areas have changed?

Amongst the areas of the standard that have been revised or now contain more specific information, organisations should pay attention to a] increased emphasis on top management engagement with ISO 9001 (clause 5), b] managing change (clause 6), c] performance and evaluation (clause 7), d] management review (clause 9) and e] repeat references to the process approach (several clauses).
What does ISO/DIS 9001:2014 mean for organisations worldwide?

The potential organisational impact of ISO/DIS 9001:2014 is dependent upon the organisation and their individual QMS. Factors such as the maturity and complexity of the existing ISO 9001:2008 management system, the existence of other management systems (such as ISO 14001 or OHSAS 18001) and the organisation’s current evaluation and management of risk will all heavily influence the degree of change that an organisation will need to undertake in order to meet these future requirements of ISO 9001:2015.

LRQA’s proposed next steps for organisations

1. Start with the DIS and focus on the areas that are completely new or have been revised. Those are the areas that are likely to be included in your transition plan. Also, make sure that quality managers and internal auditors understand the differences that Annex SL will bring to your QMS and any other MSS in your organisation.

2. Ensure that your certification body not only understands the DIS, but more importantly, understands what the DIS means to your QMS and wider organisation.

3. Engage your certification body to find out how a gap analysis and training on specific areas of ISO 9001:2015 can benefit you personally, as well as your organisation.

4. Formalise a transition plan and process and ensure that top management is involved from the start.

News

Speaking at a conference in London organised by the International Organization for Standardization (ISO) recently, Marcus Long, CEO of the Independent International Organisation for Certification (IIOC), demonstrated the tangible benefits of accredited certification to ISO standards on organisations, and relatedly the impact this has on insurers.

Following an extensive audit by the United Kingdom Accreditation Service (UKAS), LRQA has been granted accreditation to ISO 13485:2016, the international quality management system (QMS) standard for organisations involved in medical device manufacturing.

Following a week of meetings in June 2016, during which ISO 45001 - the new occupational health and safety standard being developed by the International Organization for Standardization (ISO) - moved to a second draft international standard (DIS2) stage, ISO/PC 283/WG1, the Working Group responsible for developing the new standard, met three weeks ago in Lithuania.

Today, 10 November, marks World Quality Day, a global event run by the Chartered Quality Institute, whose vision is a world where all organisations optimise value for their stakeholders through excellence in governance, assurance and improvement.

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Lloyd’s Register and variants of it are trading names of Lloyd’s Register Group Limited, its subsidiaries and affiliates. Lloyd’s Register Quality Assurance Limited is a limited company registered in England and Wales, registered number 1879370. Registered office: 71 Fenchurch Street, London, EC3M 4BS, UK. A member of the Lloyd’s Register group.